Trials Sponsors Conditions Drugs Pricing

Conditions

Cirrhosis Hypertension Status;Splenectomy Venous Thrombosis

Keywords

CirrhosisHypertensionvenous thrombosisWarfarinSplenectomyAzygoportal DisconnectionLaparoscopy

Outcome Measures

Primary Outcomes (1)

Proportions of patients who will suffer PVT or spleno-mesenteric thrombosis between oral anticoagulant Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period of 3 year from randomization
3 years

Secondary Outcomes (5)

Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups
3 years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups
3 years

Study Arms (2)

Warfarin with dipyridamole

EXPERIMENTAL

From postoperative day 3, patients will receive dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin Calcium injection for first five days and Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3. Intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR. After achieving the target INR, this is to be repeated every 4 weeks. The Doppler Ultra Sonography screening will be done every 3 months to assess the occurrence of portal vein thrombus, but the medications will be continue for one year irrespective of the occurrence of portal vein thrombus.

Drug: WarfarinDrug: DipyridamoleDrug: Low Molecular Weight Heparin

Aspirin with dipyridamole

ACTIVE COMPARATOR

From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Aspirin Enterie Ccoated Tablets 100mg qd for one year.

Interventions

WarfarinDrug

From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year.

Also known as: Warfarin Sodium, Athrombine, COUMADIN, PANAWARFIN

Warfarin with dipyridamole

DipyridamoleDrug

From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
Splenomegaly with secondary hypersplenism

Sponsors & Collaborators

Yangzhou University
Otherlead

Study Sites (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

Related Publications (2)

Wu LF, Bai DS, Shi L, Jin SJ, Zhou BH, Jiang GQ. Predictors of portal vein thrombosis after laparoscopic splenectomy and azygoportal disconnection in hepatitis B cirrhosis: a prospective study. Surg Endosc. 2022 Jun;36(6):4090-4098. doi: 10.1007/s00464-021-08730-5. Epub 2021 Sep 13.
PMID: 34518951DERIVED
Bai DS, Zhou BH, Qian JJ, Zhang C, Jin SJ, Jiang GQ. Effects of laparoscopic splenectomy and azygoportal disconnection on liver synthesis function and cirrhosis: a 2-year prospective study. Surg Endosc. 2020 Nov;34(11):5074-5082. doi: 10.1007/s00464-019-07307-7. Epub 2019 Dec 9.
PMID: 31820157DERIVED

MeSH Terms

Conditions

FibrosisHypertensionVenous Thrombosis

Interventions

WarfarinDipyridamoleAspirinaspirin, magnesium oxide combinationHeparin, Low-Molecular-WeightNadroparin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesThrombosis

Study Officials

Dou-Sheng Bai, MD
Clinical Medical College of Yangzhou University
STUDY CHAIR
Guo-Qing Jiang, MS
Clinical Medical College of Yangzhou University
STUDY DIRECTOR
Ping Chen, MD
Clinical Medical College of Yangzhou University
PRINCIPAL INVESTIGATOR
Sheng-Jie Jin, MS
Clinical Medical College of Yangzhou University
PRINCIPAL INVESTIGATOR

Enrollment

124 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Master

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 25, 2014

Study Start

September 2014

Actual (reported)

Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Warfarin with dipyridamole

Aspirin with dipyridamole

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Warfarin with dipyridamole

Aspirin with dipyridamole

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations